Current jobs related to Regulatory Affairs Professional for AI Software - Frederiksberg, Frederiksberg Kommune - European Search Company
-
Regulatory Affairs Expert
7 days ago
Frederiksberg, Frederiksberg Kommune, Denmark beBee Careers Full timeJob DescriptionCerebriu is seeking a highly motivated Regulatory Affairs Specialist to join our dynamic team. As a key member of our regulatory team, you will play a pivotal role in driving our regulatory and QA efforts.This position requires a hands-on approach, contributing to both regulatory submissions and daily QA tasks. Your expertise will ensure...
-
Regulatory Affairs Specialist
4 weeks ago
Frederiksberg, Frederiksberg Kommune, Denmark European Search Company Full timeCerebriu, an award-winning health-tech startup, is at the forefront of revolutionizing the field of radiology through cutting-edge AI software. Our real-time interpretation of brain MRI images enables dynamic workflow adaptation for radiologists. As we continue to make strides in the industry, we are seeking a highly motivated and driven Regulatory Affairs...
-
Regulatory Affairs Specialist
5 days ago
Frederiksberg, Frederiksberg Kommune, Denmark beBee Careers Full timeWe are seeking a highly motivated and driven Regulatory Affairs Specialist to drive regulatory and quality assurance efforts for our software-only medical devices.The ideal candidate will pursue regulatory submissions in compliance with EU MDR, FDA, and international regulations. They will maintain and develop our ISO 13485-certified QMS tailored to...
-
Compliance Officer for Medical Software
7 days ago
Frederiksberg, Frederiksberg Kommune, Denmark beBee Careers Full timeAbout UsCerebriu is an award-winning health-tech startup at the forefront of revolutionizing the field of radiology through cutting-edge AI software. Our real-time interpretation of brain MRI images enables dynamic workflow adaptation for radiologists.We are seeking a highly motivated and driven Regulatory Affairs Specialist to join our dynamic team. As a...
-
Medical Device Regulatory Specialist
5 days ago
Frederiksberg, Frederiksberg Kommune, Denmark beBee Careers Full timeAs a Regulatory Affairs Specialist, you will play a key role in ensuring the regulatory compliance of our software-only medical devices. This includes pursuing regulatory submissions in accordance with EU MDR, FDA, and international regulations, as well as maintaining and developing our ISO 13485-certified QMS.Key Responsibilities:Manage regulatory...
-
Medical Device Compliance Specialist
7 days ago
Frederiksberg, Frederiksberg Kommune, Denmark beBee Careers Full timeAbout the RoleWe are looking for a skilled Regulatory Affairs Specialist to assume a central and diverse role in our regulatory team. You will be responsible for preparing and managing regulatory submissions for our AI solutions in compliance with EU MDR, FDA, and other international regulatory requirements.You will also contribute to maintaining and...
-
Quality Assurance and Regulatory Lead
7 days ago
Frederiksberg, Frederiksberg Kommune, Denmark beBee Careers Full timeYour ResponsibilitiesPreparation and management of regulatory submissions for our AI solutions in compliance with EU MDR, FDA, and other international regulatory requirements.Maintaining and developing our ISO 13485-certified QMS, specifically tailored to meet regulatory requirements for software-only medical devices.Keeping up to date with emerging trends...
-
Software Professional
7 days ago
Frederiksberg, Frederiksberg Kommune, Denmark beBee Careers Full timeWe are looking for a skilled Software Engineer with .NET expertise and experience in developing cloud-based software and services.Job ResponsibilitiesTranslate business requirements into technical specifications and develop software architecture and design.Implement new features, maintain and improve existing codebases, and contribute to high-level...
-
AI Innovations Leader
1 week ago
Frederiksberg, Frederiksberg Kommune, Denmark beBee Careers Full timeJob Title: AI Innovations LeaderThis role requires an experienced AI innovations leader with expertise in product and API development to spearhead our AI/NLP initiatives.The Role You'll Play:Leverage advanced AI and NLP technologies to enhance our product offerings and expand our capabilities for internal and external use.Ensure that our AI innovations are...
-
Senior AI Solutions Manager
2 weeks ago
Frederiksberg, Frederiksberg Kommune, Denmark European Search Company Full timeWe are seeking a seasoned professional to lead our diagnostic imaging product strategy. As a Senior AI Solutions Manager, you will drive the development of innovative AI-driven diagnostic imaging solutions, aligning with customer needs and market trends.About the Role:Explore markets and user needs, conducting research and segmentation analysis.Develop a...
Regulatory Affairs Professional for AI Software
3 weeks ago
Cerebriu, an award-winning health-tech startup, is pioneering the use of AI in radiology. Our real-time MRI image interpretation enables dynamic workflow adaptation for radiologists.
We are seeking a highly motivated and detail-oriented Regulatory Affairs Specialist to drive our regulatory and quality assurance efforts.
This role will be instrumental in ensuring compliance with EU MDR, FDA, and other international regulations for our software-only medical devices. Key responsibilities include preparing and managing regulatory submissions, maintaining our ISO 13485-certified QMS, and collaborating with cross-functional teams to ensure agile compliance.
Requirements:
- Bachelor's degree or higher in a related field (e.g., life sciences, engineering)
- Minimum 5 years' experience in regulatory affairs within the medical device and/or software as a medical device industry
- Strong knowledge of relevant standards and regulations, including EU MDR and FDA
- Experience in preparing and managing regulatory submissions
- Excellent written and oral communication skills in English; proficiency in Danish is a plus
- Detail-oriented with strong project management skills
Candidates should stay updated on regulatory changes and industry best practices, thrive in fast-paced environments, and drive forward-thinking approaches to regulation.
